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Thursday, June 01, 2023 6:45:42 PM
It is not accurate to suggest that there have not been any submissions to regulators. Most notably, the MIA was approved and is evidence of a regulatory filing plan that has begun to unfold. Further applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
March 2023 Manufacturing News:
![](http://investorshub.advfn.com/uimage/uploads/2023/3/26/f[zjg4B856C90-15C9-4560-A186-6E7907E6D8EF.jpeg)
![](http://investorshub.advfn.com/uimage/uploads/2022/11/14/rjw[m6B75BCC9-4218-48D3-9337-1CFDEDC7E5CF.jpeg)
https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171909324
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